Effect of Ventilation Tubes in Otitis-prone Children

NCT ID: NCT05348291

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-21
• Study Completion Date: 2033-05-31

Brief Summary

The purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. By drawing lots, young children with recurrent ear infections will be assigned to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. The study participants will be followed until they are 7 years old.

Detailed Description

Children who fulfil the criteria of recurrent acute otitis media (AOM) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). Due to the nature of the intervention, blinding will not be possible. Children randomised to are randomised to active monitoring and continue to have frequent recurrences will be given the opportunity to cross between groups.

Children will be followed by the study doctors every third month until the age of two years, and after this yearly. In addition to planned visits, the families will be advised to contact the study doctors whenever they suspect that their child has a new episode of AOM. Otomicroscopy and nasopharyngeal cultures will be performed at every visit; cultures from the external ear canal will be taken when applicable. It will also be noted whether there is any perforation of the tympanic membrane, whether ventilation tubes are still in place, whether there is an ongoing episode of AOM or of otitis media with effusion (OME). At each planned visit, a parental quality of life questionnaire for children with ear disease will be completed. It will be noted how many AOM episodes the child has had since the last planned visit, how many times the patient has been prescribed oral antibiotics (also for reasons other than AOM), and if the family has seen a doctor elsewhere. At each emergency visit, it will be noted if the child has AOM or not, whether the child has fever, any signs of complications to AOM, a spontaneous perforation and whether the child´s general well-being is affected.

At the ages of 4 and 7 years and, if a hearing impairment is suspected on any other occasion, hearing tests will be performed.

Conditions

Recurrent Acute Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ventilation tubes

Ventilation tube surgery

Group Type: ACTIVE_COMPARATOR

ventilation tubes

Intervention Type: DEVICE

Transtympanic pressure equalising devices.

Active monitoring

Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ventilation tubes

Transtympanic pressure equalising devices.

Intervention Type: DEVICE

Other Intervention Names

grommets

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Otorhinolaryngology, Head and Neck Surgery

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Marie Gisselsson-Solen, MD, PhD

Role: CONTACT

marie.gisselsson-solen@med.lu.se

+4646172815

Ann Hermansson, Professor

Role: CONTACT

ann.hermansson@med.lu.se

+4646171360

Facility Contacts

Tomas Andersson-Kronmark, MD

Role: primary

tomas.kronmark@gmail.com

Other Identifiers

Rorstudien2022

Identifier Type: -

Identifier Source: org_study_id